Category Archives: Basal Insulin

Thoughts on Lilly’s “Tempo Pen” for Connected Care

In November 2019, the product labels for Lilly’s Basaglar and Humalog were updated to include administration via a new disposable connected pen called the “Tempo Pen.” Ahead of Lilly’s Q1 ’20 earnings call on Thursday, April 23, FENIX provides thoughts on the Tempo Pen since Lilly has not made any public announcements as of yet.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Offers Free Insulin in COVID-19 Response

Novo Nordisk announced plans to give away 90-day supplies of insulin for people who have lost their health insurance due to the COVID-19 pandemic. Below, FENIX provides thoughts on Novo’s response as well as insight into how Novo could be using the program for lead generation and to neutralize biosimilar insulin competition.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lannett Bs-glargine Regulatory Update

Lannett announced it has a Biosimilar Biological Product Development Type II meeting scheduled with FDA on June 9 to discuss the next steps in the clinical advancement of its biosimilar glargine. Lannett is developing the bs-glargine in partnership with YiChang HEC ChangJiang Pharmaceutical Co. (HEC Pharm). Below, FENIX provides insights on the Lannett development program in the context of the recent insulin conversion from a drug to a biologic as well as the November 2019 immunogenicity draft guidance.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon’s Malaysian Facility Passes Pre-Approval Glargine FDA Inspection

Biocon has issued a press release announcing they received the FDA “Establishment Inspection Report” for the bs-glargine pre-approval inspection of its Malaysian manufacturing facility. The closing of the inspection comes after several failed inspections over the past few years. Below, FENIX provides thoughts on Biocon passing its inspection, including the impact on the impending June 2020 bs-glargine FDA action date.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Nemaura enters into multiple non-binding agreements for sugarBEAT; Mylan wins over Sanofi in Lantus patent litigation

A series of diabetes-related news has been observed including an announcement that Nemaura has entered into multiple non-binding agreements for its sugarBEAT CGM (press release) as well as the US District Court ruling favorably for Mylan/Biocon’s bs-glargine over Sanofi’s Lantus (press release). Below, FENIX provides brief thoughts on these announcements in the context of the recent news from Nemaura and the potential launch of Mylan/Biocon’s bs-glargine.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan Q4 ’19 Earnings Update; Bs-glargine Briefly Discussed

Mylan hosted its Q4 and FY 2019 earnings call and provided updates to its business. The vast majority of the call revolved around the pending merger with Pfizer’s Upjohn. Of note, Mylan briefly discussed the US regulatory status of its bs-glargine and bs-aspart (in partnership with Biocon). Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Oramed Oral Insulin Ph2b Cohort B Results

Oramed announced positive topline results from Cohort B of the Ph2b trial evaluating its oral insulin (ORMD-0801) in T2DM patients. Oramed also hosted an associated call with investors to discuss the results. Recall, Oramed announced results from Cohort A of this Ph2b study in November 2019, which demonstrated a statistically significant result for the QD and BID doses but not with the TID dose (previous FENIX insight). Below, FENIX provides highlights of the new data and brief thoughts in the context of the previous Ph2b results, Tresiba’s CVOT (DEVOTE), and Novo’s QW basal insulin (icodec).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

First Look at Sanofi’s Connected Insulin Pen Solutions?

During the ATTD 2020 conference, a slide was presented with what is possibly Sanofi’s connected insulin pen solutions. Below, FENIX provides pictures and brief thoughts on the potential Sanofi connected pen platform for disposable and reusable insulin pens.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.